Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer

November 17, 2020 updated by: Alexandria University

Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction.

35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21500
        • Alexandria Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The mean age of the studied patients was 44.00±9.47 years old; the youngest patient was 28 years old and the oldest one was 68 years old, the majority of patients were 40-50 years of age (54%) As regard the patients' marital status; 31 patients were married constituting 88.57 % and only 4 (11.4 %) patients were single The main complaint of 25 of them (71.42%) was painless breast lump while 8 cases (22.85%) presented with local recurrence after previous breast conservative surgery and only two case (5.7%) presented by extensive mammographic calcifications on screening mammography

Description

Inclusion Criteria:

  • Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm
  • Distance of the tumor from the nipple ≥ 2 cm
  • Cancer or microcalcifications not localized in the central field.
  • No blood secretions or other (nipple-areola complex) NAC disturbances
  • Absence of skin involvement
  • Indication to mastectomy for multifocal or diffuse microcalcifications
  • Negative intraoperative assessment of NAC-bottom

Exclusion Criteria:

  • Tumor or microcalcifications localized in the central quadrant or in the retroareolar region
  • Blood secretions or other NAC alterations
  • Positive intraoperative assessment of NAC-bottom
  • Inflammatory carcinoma
  • Paget's disease of the nipple

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients complications after nipple sparing mastectomy
Time Frame: 2017-2019
Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints
2017-2019

Secondary Outcome Measures

Outcome Measure
Time Frame
Aesthetic results assessed by Tzafetta et al scoring system
Time Frame: 2017-2019
2017-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (ACTUAL)

November 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-27-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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